Cold - sinus

Cold - sinus
SPL v1
SPL
SPL Set ID 3ae0c602-e35d-61dd-cd81-610074a1b15b
Route
ORAL
Published
Effective Date 2012-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Influenza A Virus (30 [hp_X]) American Ginseng (15 [hp_X]) Arsenic Cation (3+) (15 [hp_C]) Bryonia Alba Root (3 [hp_X]) Euphrasia Stricta Gaultheria Procumbens Top Gelsemium Sempervirens Root Calcium Sulfide Histamine Goldenseal Dichromate Ion Mercury Phosphorus Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Schoenocaulon Officinale Seed Sage Lobaria Pulmonaria Verbascum Thapsus Echinacea, Unspecified Influenza B Virus
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-04-15

Description

Cold -  Sinus  Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Purpose

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.


Medication Information

Purpose

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Description

Cold -  Sinus  Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Package Label

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

Questions Section

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256

Otc Purpose Section

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

Indications & Usage Section

Cold -  Sinus  Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Dosage & Administration Section

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Influenzinum 30x, Aralia quin. 15x, Arsenicum alb. 15x, Bryonia 15x, Euphrasia 15x, Gaultheria 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Sabadilla 15x, Salvia 15x, Sticta 15x, Verbascum 15x, Echinacea 3x, Hydrastis 3x.

Otc Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

Otc Keep Out of Reach of Children Section

Keep out of reach of children


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Cold -  Sinus  Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Influenzinum 30x, Aralia quin. 15x, Arsenicum alb. 15x, Bryonia 15x, Euphrasia 15x, Gaultheria 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Sabadilla 15x, Salvia 15x, Sticta 15x, Verbascum 15x, Echinacea 3x, Hydrastis 3x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)